Home NDC 47781-690-30 Rasagiline
Product NDC 47781-690
Requested package NDC 47781-690-30
11-digit product format 477810690
Labeler code 47781
Product ID 47781-690_1900d812-99d8-412f-300a-8b9205db5b85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rasagiline
Dosage form TABLET
Route ORAL
Labeler Alvogen, Inc.
Application ANDA201970
Marketing category ANDA
Marketing start 2019-03-01
Substance RASAGILINE MESYLATE
Active strength 1 mg/1
Pharmacologic classes Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201970-001 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 A201970-002 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201970-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2016-03-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201970-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2016-03-15 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Rasagiline
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RASAGILINE MESYLATE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LH8C2JI290 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 608328 Internal RxNorm lookup 636664 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47781-690-30 Rasagiline 30 in 1 BOTTLE, PLASTIC TABLET 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47781-690 RASAGILINE TABLET [ALVOGEN, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20241012_a62a9946-755f-47d0-afe6-edc8f7d641fe.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47781-690-30 47781069030 30 TABLET in 1 BOTTLE, PLASTIC (47781-690-30) 30 tablet 2019-03-01 0000-00-00 No No Current